Sandoz Canada submission for biosimilar etanercept accepted for review by Health Canada

June 29, 2016 7:48 AM

Sandoz Canada announced that Health Canada has accepted for review its regulatory submission for a subsequent entry biologic version (biosimilar) of etanercept, a tumor necrosis factor alpha (TNF-alpha) inhibitor.

Sandoz biosimilar etanercept was accepted by the FDA and EMA for regulatory review in the last quarter of 2015.

“With 250 million patient days of experience across the globe since being on the market, Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. These medicines generate significant savings to the Canadian healthcare system,” said Michel Robidoux, President and General Manager of Sandoz Canada.

A recent report published by IMS notes that the surge in biosimilar medicines will drive significant change in health system costs, patient access and competition by 2020, and that patient access to biologic treatments has grown by as much as 100 percent following the availability of biosimilars (“Delivering on the Potential of Biosimilar Medicines, The Role of Functioning Competitive Markets” report, IMS Institute for Healthcare Informatics, March 2016).

Last year, Sandoz Canada  received  approval from  Health Canada for a number of additional indications for PrOmnitrope®, a recombinant human growth hormone used to treat growth problems in both pediatric and adult patients. PrOmnitrope® was Canada’s first biosimilar.

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